MAM COOLER— 510(k) K093266

Substantially Equivalent

Mam International AG

FDA 510(k) clearance K093266 for MAM COOLER, Substantially Equivalent on 2010-07-27. Applicant: Mam International AG. Device class: 2.

Clearance details

Applicant: Mam International AG
Product code: Code KKO
Device class: Class 2
Regulation: 21 CFR 872.5550
Advisory panel: Dental
Date received: 2009-10-19
Decision date: 2010-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Plains, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKO

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K110615 — WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE2011-12-02
K092025 — FLUID FILLED TEETHER - GEL2011-01-27
K092781 — MAM TWISTER2010-06-23
K092494 — GEL FILLED GUM SOOTHER2010-03-01

Data sourced from openFDA. This site is unofficial and independent of the FDA.